Drug factory · FDA FEI 3005430844
The Arab Pharmaceuticals Manufacturing PSC
Abdullah II bin Al Hussein Industrial Estate, H Street, Building no. 284, Industrial City, P.O. Box: 41, Sahab, Jordan
Problems found, fixed voluntarily at FDA's last inspection, Aug 29, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2015: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9597 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 2, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 29, 2019 inspection
- Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Registered with FDA for: analysis; label; manufacture; pack.